Treatment for Depression, Postpartum

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, MD
Depression, Postpartum+3 More
Eligibility
18 - 65
Female
Eligible conditions
Select

Study Summary

The Role of Hormones in Postpartum Mood Disorders

See full description

Eligible Conditions

  • Depression, Postpartum
  • Postpartum Depression

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Treatment will improve 1 primary outcome in patients with Depression, Postpartum. Measurement will happen over the course of ongoing.

ongoing
Outcome measures will include mood, behavioral, and hormonal parameters as well as response to o-CRH.

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

2 Treatment Groups

Group 2, Continued Replacement Group
1 of 2
Group 1, Hormone and Placebo Group
1 of 2
Active Control
Non-Treatment Group

This trial requires 100 total participants across 2 different treatment groups

This trial involves 2 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

Group 1, Hormone and Placebo Group8 weeks of hormonal addback plus 4 weeks of placebo
Group 2, Continued Replacement Group12 weeks of hormone addback

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: ongoing
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly ongoing for reporting.

Closest Location

National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda, MD

Eligibility Criteria

This trial is for female patients between 18 and 65 years old. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Having a regular menstrual cycle for at least three months is one sign that you're not pregnant. show original
has been free from any type of illness for a minimum of one year; has not had a fever, rash, or other symptoms for a minimum of one year. show original
There is no history of suicide attempts or episodes requiring hospitalization for psychosis in the woman. show original
Major Depressive Disorder is a mental illness that significantly interferes with day-to-day activities show original
The individual has a history of major depression or a hypomanic/manic episode that occurred within three months of childbirth. show original
age 18-50;
must be 18-45 years of age; may not be using hormonal contraception must have a normal menstrual cycle Women who meet the following criteria are eligible to donate: They are not pregnant, not lactating, and are in good medical health show original
No medications are required, including birth control pills. show original
A person who has had a history of major depression episodes outside of pregnancy and within three months of postpartum is not likely to have postpartum depression. show original
has not had a history of suicide attempts or psychotic episodes requiring hospitalization. show original

Patient Q&A Section

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Other questions from users

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any geographic restrictions to consider when applying for this trial?

Patients from any state can participate in this trial, so long as they are able to attend all treatment sessions.

Will my insurance cover participating in this trial?

In order to understand how insurance coverage works for this trial, you will need to contact the study coordinator.

See if you qualify for this trial
Get access to this novel treatment for Depression, Postpartum by sharing your contact details with the study coordinator.